NCT01828268

Brief Summary

The purpose of this plot study is to find out the relationship between metabolic changes and anti-retroviral therapy (ART), life style and clinical conditions of HIV-infected patients using nuclear magnetic resonance (NMR) based systems biology approach and metabolomics methodology.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 10, 2013

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

6 years

First QC Date

April 5, 2013

Last Update Submit

April 26, 2017

Conditions

HIV

Keywords

HIVMetabolomics Fingerprinting

Outcome Measures

Primary Outcomes (1)

  • Dyslipidemia

    Dyslipidemia events from admission to discharge(Up to 6 months) )

Secondary Outcomes (1)

  • Lipoatrophy

    Lipoarophy events from admission to discharge (up to 6 months)

Study Arms (1)

HIV infectors

100 confirmed HIV-1 infected patients who meet inclusion criteria.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Recruit 100 HIV-infected individuals from community HIV Clinic and/or Transmitted Disease Hospital of Chengdu

You may qualify if:

  • Clinical diagnosis of HIV infection

You may not qualify if:

  • Pregnancy
  • Individual who is participating in other trial(s)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sichuan Academy of Medical Sciences,Sichuan Provincial Hospital, Metabolomics and Mutidisciplinary Laboratory

Chengdu, Sichuan, 610101, China

RECRUITING

Related Publications (6)

  • Schackman BR, Scott CA, Sax PE, Losina E, Wilkin TJ, McKinnon JE, Swindells S, Weinstein MC, Freedberg KA. Potential risks and benefits of HIV treatment simplification: a simulation model of a proposed clinical trial. Clin Infect Dis. 2007 Oct 15;45(8):1062-70. doi: 10.1086/521933. Epub 2007 Sep 4.

    PMID: 17879926BACKGROUND

  • Joly V, Flandre P, Meiffredy V, Leturque N, Harel M, Aboulker JP, Yeni P. Increased risk of lipoatrophy under stavudine in HIV-1-infected patients: results of a substudy from a comparative trial. AIDS. 2002 Dec 6;16(18):2447-54. doi: 10.1097/00002030-200212060-00010.

    PMID: 12461419BACKGROUND

  • John M, McKinnon EJ, James IR, Nolan DA, Herrmann SE, Moore CB, White AJ, Mallal SA. Randomized, controlled, 48-week study of switching stavudine and/or protease inhibitors to combivir/abacavir to prevent or reverse lipoatrophy in HIV-infected patients. J Acquir Immune Defic Syndr. 2003 May 1;33(1):29-33. doi: 10.1097/00126334-200305010-00005.

    PMID: 12792352BACKGROUND

  • Zhang F, Dou Z, Ma Y, Zhao Y, Liu Z, Bulterys M, Chen RY. Five-year outcomes of the China National Free Antiretroviral Treatment Program. Ann Intern Med. 2009 Aug 18;151(4):241-51, W-52. doi: 10.7326/0003-4819-151-4-200908180-00006.

    PMID: 19687491BACKGROUND

  • Zyromski NJ, Mathur A, Gowda GA, Murphy C, Swartz-Basile DA, Wade TE, Pitt HA, Raftery D. Nuclear magnetic resonance spectroscopy-based metabolomics of the fatty pancreas: implicating fat in pancreatic pathology. Pancreatology. 2009;9(4):410-9. doi: 10.1159/000199436. Epub 2009 May 19.

    PMID: 19451751BACKGROUND

  • Friis-Moller N, Weber R, Reiss P, Thiebaut R, Kirk O, d'Arminio Monforte A, Pradier C, Morfeldt L, Mateu S, Law M, El-Sadr W, De Wit S, Sabin CA, Phillips AN, Lundgren JD; DAD study group. Cardiovascular disease risk factors in HIV patients--association with antiretroviral therapy. Results from the DAD study. AIDS. 2003 May 23;17(8):1179-93. doi: 10.1097/01.aids.0000060358.78202.c1.

    PMID: 12819520RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma from peripheral blood

Study Officials

  • Hua JIANG, PhD

    3Sichuan Academy of Medical Science, Sichuan Provincial People's Hospital, East Branch, Metabonomics and Multidisciplinary Laboratory

    STUDY CHAIR

  • Jin PENG, Master

    3Sichuan Academy of Medical Science, Sichuan Provincial People's Hospital, East Branch, Metabonomics and Multidisciplinary Laboratory

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hua JIANG, PhD

CONTACT

+86-28-88424391hua.jiang@traumabank.org

Bing CAI, Master

CONTACT

+86-28-88424391

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2013

First Posted

April 10, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2019

Study Completion

March 1, 2020

Last Updated

April 28, 2017

Record last verified: 2017-04

Locations

CN(1)